Z-1122-2019 Class II Terminated
FDA device recall Z-1122-2019 was initiated by Becton Dickinson & Company on March 7, 2019 and is designated Class II. Reason for recall: The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cann… The recall status is terminated (terminated May 12, 2020). Affected quantity: 6,509,600.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2019
- Initiation Date
- March 7, 2019
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,509,600
Product Description
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Reason for Recall
The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
Distribution Pattern
US distribution to the states of FL and NJ.
Code Information
Lot Numbers, UDI: 18041501, (17)210315(10)18041501, (01)50885403235915. 18042501, (17)210325(10)18042501, (01)50885403235915. 18050501, (17)210405(10)18050501, (01)50885403235915. 18051501, (17)210415(10)18051501, (01)50885403235915. 18052501, (17)210425(10)18052501, (01)50885403235915. 18060501, (17)210505(10)18060501, (01)50885403235915. 18061501, (17)210515(10)18061501, (01)50885403235915. 18062501, (17)210525(10)18062501, (01)50885403235915. 18070501, (17)210605(10)18070501, (01)50885403235915. 18072501, (17)210625(10)18072501, (01)50885403235915. 18080501, (17)210705(10)18080501, (01)50885403235915. 18081501, (17)210715(10)18081501, (01)50885403235915.